Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Participants screened over a 3 week period.

Reporting Groups

Description

Lenalidomide, Dexamethasone, Bortezomib Combination

Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.

Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.

Participant Flow: Overall Study

Lenalidomide, Dexamethasone, Bortezomib Combination

STARTED

64
[1]

COMPLETED

42
[2]

NOT COMPLETED

22

Progressive disease

11

Adverse Event

3

Initiation of non-protocol therapy

3

Physician Decision

3

Death

1

Treatment delay

1

[1]

1 patient who never started treatment was excluded in the analysis.

[2]

This included patients who completed at least 8 cycles of combination therapy with all drugs.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

65 patients were enrolled and 64 were treated. One patient who was never treated was excluded from the analysis.

Reporting Groups

Description

Lenalidomide, Dexamethasone, Bortezomib Combination

Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.

Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.